Item | Specification |
Appearance | Greyish-yellow or light yellow hygroscopic powder |
Identification | HPLC: the principal peaks in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solutions of diosmin and hesperidin respectively. |
Tests- Iodine - Water - Heavy metals - Sulfated ash | ≤ 0.1% ≤ 6.0 % ≤ 20 ppm ≤ 0.2 % |
Related Substances- Acetoisovanillone (impurity A) - Isorhoifolin (impurity C) - 6-iododiosmin (impurity D) - Linarin (impurity E) - Diosmetin (impurity F) - Unspecified impurities, for each impurity - Total | ≤ 0.5% ≤ 3.0 % ≤ 0.6 % ≤ 3.0 % ≤ 2.0 % ≤ 0.4 % ≤ 8.5 % |
ASSAY(HPLC), anhydrous substance- Diosmin - Hesperidin | ≥81.0% ≥9.0% |
Particle Size | 100% pass 80 mesh sieve |
Residual Solvents- Methanol - Ethanol - Pyridine | ≤ 3000 ppm ≤ 5000 ppm ≤ 200 ppm |
Microbiological Tests- Total aerobic microbial count - Total yeasts and moulds count - Escherichia coli - Salmonella Spp. | ≤ 103 CFU/g ≤ 102 CFU/g Absent in 1 g Absent in 10 g |